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Innovent Biologics’ Picankibart Achieves Positive Results in Phase III Psoriasis Trial
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Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, has announced the successful completion of a Phase III trial for its pipeline candidate drug, picankibart (IBI112). The drug, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection, has met all primary and key secondary endpoints in the Phase III…
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Boan Biotech’s Dulaglutide Biosimilar Accepted for Review by China’s CDE
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Boan Biotech (HKG: 6955), a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) has accepted its marketing filing for BA5101, a biosimilar version of Trulicity (dulaglutide) for blood glucose control in adults with type 2 diabetes. Trulicity, originally developed by US pharmaceutical giant Eli…
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Hinova Pharmaceuticals to Present HP518 Data at ASCO, Marking First-in-Human Trial Milestone
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Hinova Pharmaceuticals (SHA: 688302), a biopharmaceutical company based in China, is scheduled to present data from the first-in-human Phase I clinical study of its drug candidate HP518 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The study is an open-label, multi-center dose escalation trial designed to evaluate…
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Henlius Biotech’s Biosimilar Rituximab Receives First Overseas Marketing Approval from Peru
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Shanghai Henlius Biotech Co., Ltd (HKG: 2696), a biopharmaceutical company based in China, has announced that it has received marketing approval from the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) of Peru for Hanlikang, a biosimilar version of Roche’s MabThera/Rituxan (rituximab). This marks the first international marketing approval for…
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Hotgen Biotech Receives FDA Clearance to Initiate Clinical Trials for SGC001
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Hotgen Biotech Co., Ltd (SHA: 688068), a biopharmaceutical company based in China, has announced that it has received clinical trial approval from the U.S. Food and Drug Administration (FDA) for its innovative drug candidate, SGC001. SGC001 is an investigational monoclonal antibody (mAb) co-developed with Capital Medical University, designed for the…
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Innovent Biologics’ Picankibart Achieves Positive Results in Phase III Psoriasis Trial
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Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, has announced the successful conclusion of a Phase III trial for its pipeline candidate drug, picankibart (IBI112). The recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection has met all primary and key secondary endpoints in the Phase III registrational study…
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Luye Pharma’s Subsidiary Gets NMPA Green Light for Biosimilar Xgeva
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Shandong Boan Biotechnology Co., Ltd (HKG: 6955), a controlling subsidiary of China-based Luye Pharma Group (HKG: 2186), has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for BA1102, a biosimilar version of Amgen’s Xgeva (denosumab). BA1102 is now approved for use in treating giant…
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RareStone Group’s Pitolisant Secures NMPA Approval to Treat Narcolepsy in Children and Adolescents
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RareStone Group, a China-based company specializing in rare diseases (formerly known as Citrine Medicine), has secured marketing approval from the National Medical Products Administration (NMPA) for pitolisant, its in-licensed drug candidate. The histamine 3 (H3) receptor antagonist/inverse agonist is now approved for treating excessive daytime sleepiness (EDS) or cataplexy in…
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Sanofi’s Sarclisa Receives FDA Priority Review for Newly Diagnosed Multiple Myeloma Treatment
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Sanofi plc (NYSE: SNY), a leading pharmaceutical company based in France, has announced that the U.S. Food and Drug Administration (FDA) has granted priority review status to a supplemental approval filing for its drug Sarclisa (isatuximab). The priority status is in recognition of the molecule’s potential use in treating adult…
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Yantai Dongcheng Pharmaceutical Receives NMPA Approval for SSTR2 Targeted Radioactive Drug
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate, 177LuLNC1010. This investigational therapy is a somatostatin receptor 2 (SSTR2) targeted radioactive drug designed for the…
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Jiangsu Hengrui’s SHR-A1921 Anticipated to Gain NMPA Breakthrough Designation for Ovarian Cancer
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that its drug candidate SHR-A1921 is on track to receive breakthrough therapy designation (BTD) from the National Medical Products Administration (NMPA) for the treatment of platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. SHR-A1921 is an antibody…
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Chinese Biopharma Companies Set to Showcase Oncology Pipelines at ASCO 2024
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A cohort of Chinese biopharmaceutical companies, including Wuhan YZY Biopharma Co., Ltd (HKG: 2496), Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), JW Therapeutics (HKG: 2126), and CStone Pharmaceuticals (HKG: 2616), are preparing to present updates on their pipeline products at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting,…
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Novartis’ Fabhalta Shows Promise in Late-Stage C3 Glomerulopathy Trial
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Novartis AG (NYSE: NVS), a leading Swiss pharmaceutical company, last week announced positive preliminary data from a late-stage study for its complement inhibitor Fabhalta (iptacopan) in patients with the ultra-rare kidney disease C3 glomerulopathy (C3G). The study showed that compared to placebo, iptacopan achieved a 35.1% reduction in proteinuria and…
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Kexing Pharmaceutical Secures NMPA Approval for Childhood Growth Hormone Deficiency Study
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Kexing Pharmaceutical (SHA: 688136), based in China, has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study targeting childhood growth hormone deficiency. The clinical trial will investigate a Category I innovative product candidate, an Fc fusion protein designed as a long-acting growth hormone. This molecule…
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Henlius Biotech’s Denosumab Biosimilar Secures EMA Review for European Market Entry
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Shanghai Henlius Biotech Inc. (HKG: 2696), a biopharmaceutical company based in China, has announced that the European Medicine Agency (EMA) has accepted two marketing approval filings for its drug candidate HLX14, a biosimilar version of Amgen’s Prolia/Xgeva (denosumab). Denosumab, a recombinant anti-RANKL human monoclonal antibody injection, is utilized for various…
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Bio-Thera Solutions Receives NMPA Approval for BAT6005 and BAT1308 Combination Therapy Trial
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Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its drug candidates BAT6005 in combination with BAT1308 for the treatment of locally advanced or metastatic solid tumors. BAT6005…
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Novartis’ Atrasentan Shows Significant Reduction in Proteinuria in IgA Nephropathy Trial
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Novartis AG (NYSE: NVS), a Swiss pharmaceutical company, last week presented interim results for the primary endpoint of a Phase III trial for atrasentan in patients with IgA nephropathy (IgAN). The trial indicated that the endothelin A (ETA) receptor antagonist demonstrated a 36.1% reduction in proteinuria at 36 weeks compared…
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AccurEdit Therapeutics Publishes Positive Data for Gene-Edited Drug ART001 in Amyloidosis Treatment
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AccurEdit Therapeutics (Suzhou) Co., Ltd., a leading gene editing therapy specialist based in China, has published the efficacy and safety data for its drug candidate ART001, which is being investigated as a treatment for transthyroxine protein amyloidosis. ART001, the first non-viral vector in vivo gene-edited drug in China to enter…
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Shanghai Fosun Pharma’s FCN-159 File for Dendritic and Histiocytic Tumors Accepted by China’s NMPA
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for the novel small-molecule drug FCN-159 for review. The drug is being considered for the treatment of dendritic and histiocytic tumors, indications that have previously…
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Akeso Biopharma’s Ivonescimab Approved for NSCLC Treatment in China
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Akeso Biopharma (HKG: 9926), a biopharmaceutical company based in China, has announced that its bispecific antibody (BsAb) ivonescimab (AK112), which targets programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), has been approved for use in combination with chemotherapy to treat locally advanced or metastatic non-squamous non-small cell lung cancer…
